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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM TI LCP SUP ANT CLAVICLE PL W/LAT EXTN 7H/LT/123MM-STER PLATE,FIXATION,BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM TI LCP SUP ANT CLAVICLE PL W/LAT EXTN 7H/LT/123MM-STER PLATE,FIXATION,BONE Back to Search Results
Catalog Number 04.112.019S
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/08/2020
Event Type  malfunction  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent the surgery for left clavicle shaft fracture with the plate in question. During the surgery, when the surgeon set the plate, the plate did not fit. The surgeon attempted to bend the plate, but the plate broke in two from the center. The surgeon used another plate and the surgery was completed successfully. There was a surgical delay of about fifteen (15) minutes. The patient was reported as stable. No further information is available. Concomitant device reported: unk- bending inst: plate bender: trauma. This report is for one (1) 3. 5mm ti lcp sup ant clavicle pl w/lat extn 7h/lt/123mm-ster. This is report 1 of 1 for (b)(4).
 
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Brand Name3.5MM TI LCP SUP ANT CLAVICLE PL W/LAT EXTN 7H/LT/123MM-STER
Type of DevicePLATE,FIXATION,BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES SELZACH
bohackerweg 5
selzach 2545
SZ 2545
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10779064
MDR Text Key214380015
Report Number8030965-2020-08515
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K111540
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.112.019S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/03/2020 Patient Sequence Number: 1
Treatment
UNK - BENDING INSTRUMENTS: PLATE BENDER: TRAUMA
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